What classification system categorizes medical devices based on infection risk?

The Spaulding Classification System is specifically designed to categorize medical devices based on the risk of infection they pose to patients. This system divides devices into three categories: critical, semi-critical, and non-critical. Critical items, which enter sterile tissue or the vascular system, require sterilization due to their high risk of infection. Semi-critical items, which contact mucous membranes, must be high-level disinfected, while non-critical items only need cleaning or low-level disinfection.

This classification is essential in guiding infection control practices to ensure that appropriate measures are taken to prevent the transmission of infectious agents, particularly for procedures involving flexible endoscopes, which often come into contact with high-risk areas. Understanding this classification helps reprocessing staff determine the appropriate level of cleaning, disinfection, or sterilization needed for each type of medical device they are responsible for.

Other options, such as Recommended Practices and Quality Assurance, relate more to guidelines and protocols in healthcare settings but do not specifically focus on the classification of medical devices concerning infection risk. The SDS, or Safety Data Sheet, is a document that provides information on the properties and safe use of hazardous materials but is not a classification system for medical devices. Thus, the Spaulding Classification System stands out as the